Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin

Not Applicable

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Device: 595 nm Pulsed dye laser (Candela V-beam perfecta)

• Registration Number: NCT05079256
• Lead Sponsor: Nick van der Beek

Brief Summary

The researchers investigate the effect of a treatment with selective photothermolysis using a 595 nm pulsed dye laser on the blood vessel density and the nerve fibre density of a psoriatic lesion. By comparing tissue samples collected before and after two treatments, the researchers determine the relative effect of laser therapy on the (hyper)innervation of psoriatic skin.

Detailed Description

Vascular laser therapy for psoriasis seems to achieve a remarkably long treatment-free duration of remission. But why would sub-second heating of the blood vessels of the skin result in a year-long resolution of an infamously stubborn condition?

Unraveling the mechanism of action of laser therapy would not only allow for the improvement of existing laser therapy protocols but also, could open the door to a whole new range of interventions offering quasi-permanent solutions for patients. There is a high need for such enduring therapies: Psoriasis is both, a common and a costly skin condition. It affects between 1% and 9% of the population and has a very severe impact on the quality of life of the patient. It's chronic character implies lifelong treatment, and the associated risks and effort

This project aims to assess the effect of laser therapy on the blood vessels and (peripheral) innervation of psoriasis plaques. The primary objective is to quantify the regression and recovery of nerves compared to blood vessels. The researchers hypothesize that the recovery of nerves after Selective Photo Thermolysis (SPT) is decreased compared to the recovery of blood vessels.

Study Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-15
• Study Start: 2022-12-09
• Primary Completion: 2024-10-12
• Study Completion: 2024-10-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 18 - 69 years of age
• Psoriasis vulgaris
• Skin type I - III
• Minimal surface of lesion of 3 cm2
• Contralateral psoriasis vulgaris lesions located on chest, back, or upper legs

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study if:

• The participant uses other treatments (than laser therapy) during the study or two weeks before the start of the study that are known to affect psoriasis
• The participant suffers from any known neurological, vascular, or immunological condition other than psoriasis.
• The participant is allergic to lidocaine

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Laser therapy	595 nm Pulsed dye laser (Candela V-beam perfecta)	595 nm Pulsed dye laser (PDL) therapy for psoriasis

Primary Outcome Measures

Name	Time	Method
Recovery ration	6 months.	Relative change in the ratio of the linear nerve density and linear blood vessel density.

Secondary Outcome Measures

Name	Time	Method
Recovery ratio vs lymphocyte infiltration	6 months	Correlation between change in the ratio of the linear nerve density and linear blood vessel density versus change in number of infiltrating lymphocytes
Clinical improvement	6 months	Change in severity determined using a visual-analogue scale.

Trial Locations

Locations (1)

ZBC MultiCare; 🇳🇱 Hilversum, Noord-Holland, Netherlands